Aethlon Medical (NASDAQ: $AEMD) Announces the
Conclusion of Hemopurifier Clinical Study
SAN DIEGO, CA - March 13, 2017 (Investorideas.com
Newswire) Aethlon Medical, Inc. (Nasdaq: AEMD), a therapeutic
technology company focused on unmet needs in global health and biodefense,
announced today that the company has concluded an FDA-approved feasibility
study designed to assess the safety of the Aethlon Hemopurifier® in
health-compromised individuals. The single-site study was conducted at DaVita
Med Center Dialysis in Houston, Texas.
The Hemopurifier is a first-in-class medical device
that reduces the presence of circulating viruses in infected individuals. The
technology is a first-line candidate defense against a broad-spectrum of
viruses that are not addressed with antiviral drug therapies, including natural
occurring pandemic threats and agents of bioterrorism. Additionally, the
device provides a strategy to augment the benefit of proven antiviral drug
regimens.
The Hemopurifier had previously been administered to
individuals infected with Hepatitis C virus (HCV), HIV and the Ebola virus, for
which it was approved by the FDA under Emergency-Use Authorization.
In the feasibility study, the Hemopurifier was
observed to be well tolerated in End-Stage Renal Disease (ESRD) volunteers who
were also infected with Hepatitis C virus (HCV). The inclusion of HCV-infected
ESRD subjects served as a model to demonstrate virus reduction. No device-related
adverse events were observed in enrolled subjects who met the study
inclusion/exclusion criteria.
The study originally was estimated to enroll ten
subjects, but was concluded after the treatment of eight subjects based on the
Hemopurifier being well-tolerated in the study, the breadth of previous human
treatment experiences and the absence of qualified HCV-infected ESRD candidates
at the study location.
"We achieved our primary study objective, which
was to demonstrate that our Hemopurifier can be safely administered to very
health-compromised individuals," stated Jim Joyce, Chairman and CEO of
Aethlon Medical. "We will now proceed to submit a final report and look
forward to collaborating with our FDA review team to establish market clearance
pathways to treat viral threats that are not well addressed with traditional
drug therapies."
In preclinical studies, the Hemopurifier has been
demonstrated to capture a wide-range of bioterror and pandemic threats that are
not addressed with antiviral drug therapies.
Aethlon believes the device can fulfill the
broad-spectrum medical countermeasure objective of the U.S. Department of
Health and Human Services (HHS) Public Health Emergency Medical Countermeasure
Enterprise (PHEMCE). This initiative is directed toward bioterror,
pandemic threats and other pathogens that are not well addressed with drug or
vaccine therapies.
The Company also seeks to advance the Hemopurifier
under the provisions of the 21st Century Cures Act, which was signed into law
in December 2016. The Act establishes new rules that direct the FDA to
approve drugs and devices with greater urgency. Specific to medical
devices, the Act requires the FDA to establish a priority review program for
"breakthrough" devices, or for devices that target diseases for which
no FDA-cleared or approved alternatives are available.
About The Study Protocol
The study was a single-arm, sequential, controlled
feasibility/safety study in which each enrolled subject served as his/her own
control. The control period was the week immediately preceding the
administration of Hemopurifier therapy, during which eligible subjects were
monitored during three standard intermittent hemodialysis sessions, which are
require to maintain the life of ESRD patients. Collected data points included
vital signs, blood chemistries, hematology and liver function. On weeks two and
three, enrolled subjects received the administration of Hemopurifier® therapy
three times per week (6-Hemopurifier treatments in total) coincident with their
ongoing standard intermittent hemodialysis treatments. During these two weeks,
subjects were assessed for the same clinical parameters as during the control
period. The collected data will be included in a final report to be
provided to FDA. The final report will also include observations of viral
load reduction during treatment, as well as a quantitative post-treatment
assessment of total viruses captured within the Hemopurifier.
About Aethlon Medical, Inc.
Aethlon Medical develops immunotherapeutic
technologies to combat infectious disease and cancer. To augment the body's
natural immune defenses, the Aethlon Hemopurifier® reduces the presence of
circulating viruses in infected individuals. The technology provides a
first-line candidate defense against viruses that are not addressed with proven
drug therapies, including natural occurring pandemic threats and agents of
bioterrorism. The Hemopurifier® can also be deployed as a strategy to improve
the benefit of approved antiviral drug regimens. At present, the Hemopurifier®
is being advanced in the United States under an FDA approved clinical
study. Aethlon Medical is also investigating the potential use of the
Hemopurifier® to reduce the presence of tumor-derived exosomes, which
contribute to immune-suppression and the spread of metastasis in cancer
patients. Aethlon Medical is also the majority owner of Exosome Sciences, Inc.
(ESI), which is focused on the discovery of exosomal biomarkers to diagnose and
monitor cancer and neurological disorders, including Alzheimer's disease (AD)
and Chronic Traumatic Encephalopathy (CTE). ESI's TauSome™ biomarker is
being clinically evaluated as the basis for a blood-based test to identify CTE
in living individuals. Additional information can be found online at www.AethlonMedical.com and www.ExosomeSciences.com. You can also connect with us on Twitter, LinkedIn, Facebook and
Google+.
This press release contains forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933 and Section 21E
of the Securities Exchange Act of 1934 that involve risks and uncertainties.
Statements containing words such as "may," "believe,"
"anticipate," "expect," "intend,"
"plan," "project," "will,"
"projections," "estimate," or similar expressions
constitute forward-looking statements. Such forward-looking statements are
subject to significant risks and uncertainties and actual results may differ
materially from the results anticipated in the forward-looking statements.
Factors that may contribute to such differences include, without limitation,
the Company's ability to maintain its listing on the Nasdaq Capital Market, or
any other national securities exchange, that the Company or its subsidiary will
not be able to commercialize its products, including any CTE-related products,
that the FDA will not approve the initiation or continuation of the Company's
clinical programs or provide market clearance of the Company's products,
including clearance through the 21st Century Cures Act, the Company's
ability to raise capital when needed, the Company's ability to complete the
development of its planned products, the Company's ability to manufacture its
products either internally or through outside companies, the impact of
government regulations, patent protection on the Company's proprietary
technology, the ability of the Company to meet the milestones contemplated in
its contract with DARPA, product liability exposure, uncertainty of market
acceptance, competition, technological change, and other risk factors. The
foregoing list of risks and uncertainties is illustrative, but is not
exhaustive. Additional factors that could cause results to differ materially
from those anticipated in forward-looking statements can be found under the
caption "Risk Factors" in the Company's Annual Report on Form 10-K
for the year ended March 31, 2016, and in the Company's other filings with the
Securities and Exchange Commission. Except as may be required by law, the
Company does not intend, nor does it undertake any duty, to update this
information to reflect future events or circumstances.
Contacts:
Jim Frakes
Chief Financial Officer
Aethlon Medical, Inc.
858-459-7800 extension 3300
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